Duns Number:041810693
Catalog Number
-
Brand Name
Retract-o-Tape 18g x 35.6cm Thin Wall w Needle_non sterile
Version/Model Number
1291
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAE
Product Code Name
Snare, Surgical
Public Device Record Key
ae8d782d-59e6-4e6a-8d28-d9b530569b02
Public Version Date
November 13, 2019
Public Version Number
2
DI Record Publish Date
October 10, 2019
Package DI Number
20634624012916
Quantity per Package
500
Contains DI Package
10634624012919
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 168 |
U | Unclassified | 8 |